This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells

Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR] [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Secondary Outcome Measures:

Complete response rate estimated by the number of confirmed complete responses (CR) observed in the trial divided by the total number of evaluable patients [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Overall survival [ Time Frame: From the date of registration to the date of death, assessed up to 5 years ] [ Designated as safety issue: No ]

Estimated using the Kaplan-Meier method.

Time to progression as estimated by Kaplan-Meier method [ Time Frame: From the date of registration to the date of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]

Estimated using the Kaplan-Meier method.

Duration of response [ Time Frame: From the date at which the patient's objective status is first noted to be a response to the date that progression or death is documented, assessed up to 5 years ] [ Designated as safety issue: No ]

V. Perform preclinical testing of AZD2171 in the induction of B-CLL cell apoptosis/cell death using pretreatment samples, and evaluate the ability to downregulate the phosphorylation status of VEGFR-2 of B-CLL cells by comparing in vitro samples with and without AZD2171.

VI. Study the differences in in vitro levels of B-CLL cell apoptosis/cell death and alteration of VEGFR-2 phosphorylation using pretreatment samples with and without AZD2171 and how these differences correlate with clinical outcomes.

VII. Assess if the clinical responses are associated with changes in bone marrow vascularity.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sampling and biopsies at baseline and periodically throughout study for biomarker and correlative studies.

After completion of study therapy, patients are followed periodically for up to 5 years from study entry.

No other uncontrolled illness including, but not limited to, the following:

Hypertension

Ongoing or active infection

Symptomatic congestive heart failure

Unstable angina pectoris

Cardiac arrhythmia

Psychiatric illness or social situations that would limit compliance

See Disease Characteristics

More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, anti-vascular endothelial growth factor (VEGF) treatment, or major surgery and recovered

More than 30 days since prior investigational agents

No concurrent drugs or biologics with proarrhythmic potential

No other concurrent investigational agents

No other concurrent anticancer therapy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00321724